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Abstract:

A drug administration safety device having a label configured to be
attached to a drug container such as a syringe or IV bag, an adhesive on
the back face of the label, and a backing or substrate for holding the
label and protecting the adhesive prior to the application of the label
to the drug container. In one embodiment, the label includes a first drug
name section in a first orientation, a second drug name section in a
second orientation, a third drug name section in a third orientation, a
drug concentration section, a variable information section, and a
gradiation viewing section. The first orientation, second orientation,
and third orientation are different from each other to enable a user to
readily see the drug name regardless of the position and orientation of
the drug container.

Claims:

1. A drug administration safety device comprising: a single label
configured to be attached to a drug container, said drug container
including an operating room intravenous syringe configured to contain a
drug, said drug having a name including a plurality of letters, said
single label including an interior surface and an exterior surface, said
single label including: (a) a first drug name section in a first
orientation, said first drug name section including the letters of the
name of the drug, said first drug name section readable when looking at
said exterior surface, said letters of the name of the drug in the first
drug name section being positioned in said first drug name section such
that when the single label is attached to the syringe, said letters of
the name of the drug are positioned along a longitudinal section of the
syringe and are upright when a plunger of the syringe is positioned below
the single label, (b) a second drug name section in a second orientation,
said second orientation being different from said first orientation, said
second drug name section including the letters of the name of the drug,
said second drug name section readable when looking at said exterior
surface, (c) a third drug name section in a third orientation, said third
orientation being different from said first orientation, and said third
orientation being different from said second orientation, said third drug
name section including the letters of the name of the drug, said third
drug name section readable when looking at said exterior surface, (d) a
drug concentration section, (e) a variable information section, and (f) a
graduation viewing section configured to reveal certain portions of the
syringe that have information displayed by the syringe or affixed to a
surface of the syringe; an adhesive on the interior surface of the single
label; and a backing for holding the single label and protecting the
adhesive prior to the application of the single label to the syringe.

2. The drug administration safety device of claim 1, wherein the single
label includes a fourth drug name section in a fourth orientation, said
fourth orientation being different from the first, second and third
orientations, said fourth drug name section including the letters of the
name of the drug, said fourth drug name section readable when looking at
said exterior surface.

4. A method of reducing the risk of error in administration of a drug
from a drug container to a patient, said drug having a name including a
plurality of letters, said drug container including an operating room
intravenous syringe, said method comprising: making a single label
configured to be attached to the syringe, said single label including an
interior surface and an exterior surface, said single label including:
(a) a first drug name section in a first orientation, said first drug
name section including the letters of the name of the drug, said first
drug name section readable when looking at said exterior surface, said
letters of the name of the drug in the first drug name section being
positioned in said first drug name section such that when the single
label is attached to the syringe, said letters of the name of the drug
are positioned along a longitudinal section of the syringe and are
upright when a plunger of the syringe is positioned below the single
label, (b) a second drug name section in a second orientation, said
second orientation being different from said first orientation, said
second drug name section including the letters of the name of the drug
said second drug name section readable when looking at said exterior
surface, (c) a third drug name section in a third orientation, said third
orientation being different from said first orientation, and said third
orientation being different from said second orientation, said third drug
name section including the letters of the name of the drug, said third
drug name section readable when looking at said exterior surface, (d) a
drug concentration section, (e) a variable information section, and (f) a
graduation viewing section configured to reveal certain portions of the
syringe that have information displayed by the syringe or affixed to a
surface of the syringe; providing an adhesive on the interior surface of
the single label; providing a backing for holding the single label and
protecting the adhesive prior to the application of the single label to
the syringe; removing the backing from the single label and attaching the
single label without the backing to the syringe; and providing the drug
container for administration of the drug from the drug container.

5. The method of claim 4, which includes making the single label to
include a fourth drug name section in a fourth orientation, said fourth
orientation being different from the first, second and third
orientations.

6. The method of claim 4, which includes providing the graduation viewing
section in an L-shape configuration.

7. A drug container labeling system for a drug, said system comprising:
(a) a first label for a first drug container, said first label including:
(i) a first drug name section including a name of the drug in the first
drug container, and (ii) a first drug concentration section including an
identification of a first concentration of the drug in the first drug
container, wherein a first drug concentration indicator is associated
with the first drug concentration section; and (b) a second label for a
second drug container, said second label including: (i) a second drug
name section including the name of the drug in the second drug name
section, wherein the name of the drug in the second drug name section is
the same as the name of the drug in the first drug name section, and (ii)
a second drug concentration section including an identification of the
second concentration of the drug in the second drug concentration
section, wherein the second concentration of the drug in the second drug
concentration section is different from the first concentration of the
drug in the first drug concentration section, wherein a second drug
concentration indicator is associated with the second drug concentration
section, and wherein said second drug concentration indicator is
different from the first drug concentration indicator.

8. The drug container labeling system of claim 7, wherein the drug
container is selected from the group consisting of an intravenous
solution bag, a pump cassette, a vial and a syringe.

9. The drug container labeling system of claim 7, wherein at least one
of: the first drug concentration indicator is configured on the first
label to surround the identification of the first drug concentration of
the first drug concentration section and the second drug concentration
indicator is configured on the second label to surround the
identification of the second drug concentration of the second drug
concentration section.

10. The drug container labeling system of claim 7, wherein at least one
of: the first drug concentration indicator is configured on the first
label to be adjacent to the identification of the first drug
concentration of the first drug concentration section and the second drug
concentration indicator is configured on the second label to be adjacent
to the identification of the second drug concentration of the second drug
concentration section.

11. The drug container labeling system of claim 7, wherein a third
indicator is associated with the first drug name section and the first
drug concentration section, and wherein a fourth drug concentration
indicator is associated with the second drug name section and the second
drug concentration section, wherein said fourth drug concentration
indicator is different from said third drug concentration indicator.

12. The drug container labeling system of claim 7, wherein at least one
of the first drug concentration indicator or the second drug
concentration indicator is of a form selected from the group consisting
of: a shape; a plurality of shapes; a first shape within a second shape,
wherein said first shape and said second shape are the same; a first
shape within a second shape, wherein said second shape is different from
said first shape; a first color within a first shape and a second color
within a second shape, wherein said first color and said second color are
the same; and a first color within a first shape and a second color
within a second shape, wherein said second color is different from said
first color.

13. The drug container labeling system of claim 7, wherein each of the
first label and the second label includes a warning statement section.

14. The drug container labeling system of claim 13, wherein the warning
statement section includes a route of administration of the drug in the
first drug container and the second drug container.

15. The drug container labeling system of claim 13, wherein a warning
indicator is associated with the warning statement.

16. A drug container comprising: a container, said container including an
operating room intravenous syringe; a drug contained within the syringe,
said drug having a name including a plurality of letters; and a single
label attached to the syringe, said single label including an interior
surface and an exterior surface, said single label including: (a) a first
drug name section configured in a first orientation on the single label,
said first drug name section readable when looking at said exterior
surface, said first drug name section including the letters of the name
of the drug being positioned in said first drug name section such that
said letters of the name of the drug are positioned along a longitudinal
section of the syringe and are upright when the syringe is viewed from a
first position where a plunger of the syringe is positioned below the
single label, (b) a second drug name section configured in a second
orientation on the single label, said second drug name section readable
when looking at said exterior surface, said second drug name section
including the letters of the name of the drug being upright when the
syringe is viewed from a second position, said second orientation being
different from said first orientation, said second position being
different from said first position, (c) a third drug name section
configured in a third orientation on the single label, said third drug
name section readable when looking at said exterior surface, said third
drug name section including the letters of the name of the drug being
upright when the syringe is viewed from a third position, said third
orientation being different from said first orientation, said third
orientation being different from said second orientation, said third
position being different from said first position, and said third
position being different from said second position, (d) a drug
concentration section, and (e) a variable information section.

17. The drug container of claim 16, wherein the single label includes a
fourth drug name section in a fourth orientation, said fourth orientation
being different from the first, second and third orientations, said
fourth drug name section including the letters of the name of the drug
being upright when the syringe is viewed from the first position.

18. The drug container of claim 16, which includes an indicator
associated with at least one of the first drug name section, the second
drug name section, the third drug name section and the drug concentration
section.

19. The drug container of claim 18, wherein the indicator is of a form
selected from the group consisting of: a shape; a plurality of shapes; a
first shape within a second shape, wherein said first shape and said
second shape are the same; a first shape within a second shape, wherein
said second shape is different from said first shape; a first color
within a first shape and a second color within a second shape, wherein
said first color and said second color are the same; and a first color
within a first shape and a second color within a second shape, wherein
said second color is different from said first color.

20. A drug administration safety device comprising: a single label
configured to be attached to an operating room intravenous syringe
containing a drug, said drug having a name including a plurality of
letters, said drug being of a designated concentration, said single label
including an interior surface and an exterior surface, said single label
including: (a) first drug name letters including the letters of said name
of the drug contained within the syringe, said first drug name letters
readable when looking at said exterior surface, said first drug name
letters being upright when the syringe with the single label attached is
viewed from a first position, said first drug name letters being of a
first size, (b) second drug name letters including the letters of said
name of the drug contained within the syringe, said second drug name
letters readable when looking at said exterior surface, said second drug
name letters being upright when the syringe with the single label
attached is viewed from a second position, said second position and said
first position being the same, said second drug name letters being of a
second size, said second size being different from said first size, (c)
third drug name letters including the letters of said name of the drug
contained within the syringe, said third drug name letters readable when
looking at said exterior surface, said third drug name letters being
upright when the syringe with the single label attached is viewed from a
third position, said third position being different from said first
position, said third position being different from said second position,
said third drug name letters being of a third size, said third size being
different from said first size, and said third size being different from
the second size, such that when the single label is attached to the
syringe, in one of the first position, the second position, and the third
position, a plunger of the syringe is below the drug name letters, (d)
drug concentration letters and numbers indicating the designated
concentration of the drug contained within the syringe, and (e) variable
information letters and numbers indicating other information relating to
the drug contained within the syringe; an adhesive on the interior
surface of the single label; and a backing for holding the single label
and protecting the adhesive prior to the application of the single label
to the syringe.

21. The drug administration safety device of claim 20, wherein the single
label includes fourth drug name letters including said letters of the
name of the drug contained within the syringe, said fourth drug name
letters readable when looking at said exterior surface, said fourth drug
name letters being upright when the syringe with the single label
attached is viewed from a fourth position, said fourth position being
different from said first position, said second position and said third
position.

22. The drug administration safety device of claim 20, wherein the single
label includes a fourth drug name letters including said letters of the
name of the drug contained within the syringe, said fourth drug name
letters readable when looking at said exterior surface.

23. A drug container comprising: an operating room intravenous syringe; a
drug contained within the syringe, said drug having a name including a
plurality of letters, said drug being of a designated concentration; and
a single label attached to the syringe, said single label including an
interior surface and an exterior surface, said single label including:
(a) first drug name letters including the letters of said name of the
drug contained within the syringe, said first drug name letters readable
when looking at said exterior surface, said first drug name letters being
upright when the syringe is viewed from a first position, said first drug
name letters being of a first size, (b) second drug name letters
including the letters of said name of the drug contained within the
syringe, said second drug name letters readable when looking at said
exterior surface, said second drug name letters being upright when the
syringe is viewed from a second position, said first position and said
second position being the same, said second drug name letters being of a
second size, said second size being different from said first size, (c)
third drug name letters including the letters of said name of the drug
contained within the syringe, said third drug name letters readable when
looking at said exterior surface, said third drug name letters being
upright when the syringe is viewed from a third position, said third
position being different from said first position, said third position
being different from said second position, said third drug name letters
being of a third size, said third size being different from said first
size, and said third size being different from the second size, such that
in one of the first position, the second position, and the third
position, a plunger of the syringe is below the drug name letters, (d)
drug concentration letters and numbers indicating the designated
concentration of the drug contained within the syringe, and (e) variable
information letters and numbers indicating other information relating to
the drug contained within the syringe.

24. The drug container of claim 23, wherein the single label includes
fourth drug name letters including said letters of the name of the drug
contained within the syringe, said fourth drug name letters readable when
looking at said exterior surface, said fourth drug name letters being
upright when the syringe is viewed from a fourth position, said fourth
position being different from said first position, said second position
and said third position.

25. The drug container of claim 23, wherein the single label includes a
fourth drug name letters including said letters of the name of the drug
contained within the syringe, said fourth drug name letters readable when
looking at said exterior surface.

Description:

PRIORITY CLAIM

[0001] This continuation patent application claims priority to and the
benefit of U.S. patent application Ser. No. 12/123,301, filed May 19,
2008, which is a non-provisional patent application which claims priority
to and the benefit of U.S. Patent Application No. 60/991,994, filed Dec.
3, 2007, the entire contents of which are incorporated herein by
reference.

COPYRIGHT NOTICE

[0002] A portion of the disclosure of this patent document contains or may
contain material which is subject to copyright protection. The copyright
owner has no objection to the photocopy reproduction by anyone of the
patent document or the patent disclosure in exactly the form it appears
in the Patent and Trademark Office patent file or records, but otherwise
reserves all copyright rights whatsoever.

BACKGROUND

[0003] According to the Institute of Medicine (IOM), medication or
pharmaceutical errors harm at least 1.5 million people every year in the
United States alone. The IOM further reports that at least one medication
error per patient per day has occurred in each hospital in the United
States during the 2006-2007 timeframe.

[0004] More specifically, if a drug is not promptly administered and
delivered to a patient to correct a deviation from normal physiological
parameters, a series of abnormal functions by the patient's body may
result. For example, a patient under anesthesia during surgery may
require prompt intervention to maintain certain systems and functions of
the patient's body such as blood pressure, fluid balance and the like. An
anesthesiologist or certified registered nurse anesthetist often must
quickly use drugs at various different concentrations to counteract the
stress on these systems and functions due to the surgery.

[0005] To administer and deliver a drug quickly to a patient, health care
providers use routes of administration such as intravenous (IV) access to
deliver drugs in liquid form to the patient. Many drugs are formulated to
be administered by pump, IV container or by syringe and are pre-filled
into these drug devices or containers for administration. A drug in the
device or container is also formulated at a predetermined concentration
to enable a suitable dose of the drug to be delivered in an appropriate
volume, thereby eliminating the need for recalculating the dose or
diluting the drug prior to its administration or between administrations.
When using pre-filled syringes, for example, each containing a
predetermined concentration of the drug for quick delivery of a drug to a
patient, a health care provider (such as an anesthesiologist) must have
readily available multiple similar syringes for multiple drugs and
multiple similar syringes of different concentrations of the same drug.
This may increase the likelihood of medication errors.

[0006] Certain steps have been taken to attempt to minimize errors in the
administration of medications. For example, the American Society for
Testing and Materials (ASTM) has established color schemes for labels to
distinguish drug classes from one another. However, errors in
administration of such drugs and medication to patients continue to
persist. There is therefore a need for improved devices which further
minimize drug or medication administration errors.

SUMMARY

[0007] The present disclosure provides various embodiments for a drug
administration safety device which includes a label configured to be
attached to a drug container such as a syringe or IV bag, an adhesive on
the back face of the label, and a backing or substrate for holding the
label and protecting the adhesive prior to the application of the label
to the drug container. In various embodiments, the label includes
multiple sections. In one embodiment, the label includes a first drug
name section in a first orientation, a second drug name section in a
second orientation, a third drug name section in a third orientation, a
drug concentration section, a variable information section, and a
graduation viewing section. The first orientation, second orientation,
and third orientation are different from each other to enable a user to
readily see (in an upright readable position) the drug name regardless of
the position and orientation of the drug container. In a further
embodiment, the label includes a fourth drug name section in a fourth
orientation, which is also different from the first, second and third
orientations. The present disclosure also provides a drug container
having the label attached to the drug container by the adhesive.

[0008] In further embodiments, each label for a specific drug
concentration section includes one or more specific shapes associated
with such concentration. Thus, different labels for different
concentrations of the same drug will have different shapes in the
respective drug concentration sections of the different labels.

[0009] The present disclosure also provides various embodiments for
developing schemes for differentiating labels for different
concentrations of the same drug. In an embodiment, each of a sequence of
different shapes is associated with each of the different concentrations
of the same drug. The shape corresponding to the concentration to be
included on a label for that drug is used in the drug concentration
sections of the label for that drug.

[0010] An advantage of the present disclosure includes providing a drug
administration safety device that reduces the risk of errors in
administration of medication by presenting certain information in the
label in various orientations to enable the user to readily read or
recognize the information regardless of the position of the drug
container.

[0011] Another advantage of the present disclosure includes providing a
drug administration safety device that reduces errors in administration
of medication by distinguishing similar drug containers for the same drug
through the use of different visual cues such as different shapes
associated with different concentrations of the drug.

[0012] A further advantage of the present disclosure is the creation of a
systematic way of distinguishing different doses of the same drug through
a sequence of different shapes associated with a sequence of increased
doses of the drug and using the same or similar sequence of shapes
associated with a sequence of increased doses of another drug.

[0013] Additional features and advantages are described herein, and will
be apparent from the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

[0014]FIG. 1 is a cross-section of a drug administration safety device of
an embodiment of the present disclosure;

[0017] FIGS. 4A, 4B, and 4C are perspective views of an embodiment of the
label of the drug administration safety device affixed to a syringe, each
figure having the syringe oriented in a different position;

[0018]FIG. 4D is a perspective view of an alternative embodiment of the
label of the drug administration safety device affixed to a syringe;

[0019]FIG. 5 is a perspective view of embodiments of the labels of the
drug administration safety devices affixed to syringes in place on a
three-port stopcock manifold;

[0020]FIG. 6 is a perspective view of an embodiment of the label of the
drug administration safety device affixed to a syringe in use by a user;
and

[0021]FIG. 7 is a plan view of a scheme for differentiating information
on drug administration safety devices.

[0022] FIG. 8 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0023]FIG. 9 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0024]FIG. 10 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0025]FIG. 11 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0026]FIG. 12 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0027]FIG. 13 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0028]FIG. 14 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0029]FIG. 15 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0030]FIG. 16 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0031]FIG. 17 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0032]FIG. 18 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0033]FIG. 19 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0034]FIG. 20 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0035]FIG. 21 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0036]FIG. 22 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0037] FIG. 23 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0038]FIG. 24 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0039]FIG. 25 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0040]FIG. 26 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0041]FIG. 27 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0042]FIG. 28 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0043]FIG. 29 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0044] FIG. 30 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0045]FIG. 31 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0046]FIG. 32 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0047]FIG. 33 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0048]FIG. 34 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0049]FIG. 35 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0050]FIG. 36 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0051]FIG. 37 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0052]FIG. 38 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0053]FIG. 39 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0054]FIG. 40 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0055]FIG. 41 is a plan view of a drug administration safety device of an
embodiment of the present disclosure;

[0056]FIG. 42 is a plan view of a drug administration safety device of an
embodiment of the present disclosure; and

[0057]FIG. 43 is a plan view of a drug administration safety device of an
embodiment of the present disclosure.

DETAILED DESCRIPTION

[0058] The present disclosure relates in general to apparatus and methods
for making drug delivery devices or containers safer. The present
disclosure describes various embodiments of drug administration safety
devices for a drug delivery device or drug container such as a syringe or
intravenous bag, and methods of clearly enabling users to readily
differentiate different drug containers having different drugs or
different concentrations of drugs in fast and reliable manner to minimize
the chances of drug administration errors and potential harm to patients
resulting therefrom.

[0059] Referring now to the Figures, FIG. 1, FIGS. 2A, 4A, 4B, 4C, and 5
illustrate one embodiment of the drug administration safety device of the
present disclosure, generally indicated by numeral 10a. The drug
administration safety device 10a includes a rectangular label 12a
configured to be attached to a drug container such as a syringe (i.e.,
wrapped around the syringe). For example, FIGS. 4A, 4B and 4C show label
12a removed from the backing 16 and positioned on a syringe 40. The drug
administration safety device 10a also includes an adhesive 14 on the back
face of the label 12a, and a backing or substrate 16 for holding the
label and protecting the adhesive prior to the application of the label
12a to the drug container.

[0060] The label 12a includes a first drug name section 20a in a first
orientation, a second drug name section 22a in a second orientation, a
third drug name section 24a in a third orientation, a drug concentration
section 26a, a variable information section 28a, a graduation viewing
section 30a and a trade dress section 32a. The first orientation, second
orientation, and third orientation are different from each other to
enable the information displayed to a user in such section (such as the
name and the drug dose of the drug, etc.) to be upright, regardless of
the position and orientation of the drug container as further discussed
below.

[0061] The first drug name section 20a of the label 12a is substantially
rectangular in shape and is positioned along a horizontal or
substantially horizontal axis in the upper left-hand corner of the label
12a. When affixed to a syringe 40 as illustrated in FIGS. 4A and 4B, the
first drug name section 20a is aligned with and oriented toward the port
end 42 of the syringe 40. The first drug name section 20a includes a
prominent display of the name of the drug. The color of the first drug
name section corresponds to the color code established by the ASTM for
that drug.

[0062] The second drug name section 22a includes the name of the drug
repeated side-by-side along the section. The second drug name section 22a
is positioned along the right side of the label 12a along a vertical or
substantially vertical axis and extends transverse to or perpendicular to
the orientation of the first drug name section 20a. As illustrated in
FIGS. 4A, 4B, 4C, 4D and 5, when affixed to a syringe the second drug
name section 22a is substantially aligned with and oriented along the
flange 44 of the barrel of the syringe 40.

[0063] The third drug name section 24a includes the name of the drug. The
drug name is repeated side-by-side along the section. The third drug name
section 24a is positioned adjacent to and to the right of the second drug
name section 22a along the right edge of the label and transverse or
perpendicular to the orientation of the first drug name section 20a. The
third drug name section 24a, however, is configured in an opposite or
inverted orientation to the second drug name section 22a such that the
drug name is the mirror image of the drug name in drug name section 22a
in this embodiment. As illustrated in FIGS. 4A, 4B, 4C, 4D and 5, when
affixed to a syringe, the third drug name section 24a is substantially
aligned with and oriented toward the flange 44 of the barrel of the
syringe 40.

[0064] Opposing orientations of the second drug name section 22a and the
third drug name section 24a enables the name of the drug to be displayed
in an upright position in two different orientations of the syringe
(i.e., in each respective section, the letters of the drug or other
information are positioned in an upright fashion with respect to that
section) As illustrated in FIG. 4B, the name of the drug, "Midazolam," is
oriented in an upright position in second drug name section 22a (relative
to that section) when the needle port 42 of the syringe 40 is pointed in
an upward direction. As illustrated in FIG. 4c, the name of the drug,
"Midazolam," is oriented in an upright position in the third drug name
section 24a (relative to that section) when the needle port of the
syringe is pointed in a downward direction.

[0065] In the illustrated embodiment, the drug concentration section 26a
includes the concentration or dosage strength of the drug, total amount
of the drug in the device or container, the volume and type of the
container, storage information, warning statements regarding the use of
the contents and other information regarding the contents of the drug
container.

[0066] In this illustrated embodiment, the variable information section
28a of the label is rectangular-shaped and is positioned immediately
adjacent to and below the drug concentration section 26a of the label.
The variable information section 28a is substantially white in color and
(although not illustrated) includes information that varies among
different drug administration safety devices for the same drug and
concentration and volume of drug. Information displayed in this section
28a may, for example, include a bar code, lot number, expiration date of
the drug, national drug code (NDC) number, size and type of the device or
container, service code, the date the formulation was made, recipient
information and any other suitable information. The variable information
section 28a also includes information related to the manufacturer of the
drug administration safety device, such as company name, company contact
information, corporate dress and any other suitable information.

[0067] The graduation viewing section 30a is configured to reveal certain
portions of the device or container that have information displayed on or
affixed to the surface of the device or container itself. The graduation
viewing section 30a is L-shaped forming the lower edge of the label 12a
and dividing the first drug name section 20a, concentration section 26a
and the variable information section 28a from the second drug name
section 22a. As illustrated in FIGS. 4A and 6, when the label 12a is
affixed to a syringe, the graduation viewing section 30a of the label 12a
of the present disclosure reveals the graduation markings 46 on the
syringe 40 as illustrated in FIG. 4A.

[0068] The trade name section 32a is positioned adjacent to and aligned
with the third drug name section 24a and forms the right edge of the
label 12a. When affixed to a syringe as illustrated in FIGS. 4A, 4B, 4C,
4D and 5, the trade name section 32a is substantially aligned along and
oriented toward the flange 44 of the barrel of the syringe 40. The trade
name section 32a includes the company name and trademark corporate dress.

[0069] It should be appreciated that each drug administration safety
device of the present invention may be manufactured individually or in
groups. More specifically, in one embodiment each label, adhesive and
backing is made as an individual device. In another embodiment, a
plurality of drug administration safety devices are made together in that
they share the same backing. These can be made in a roll for ease of
storage and use or application to drug containers.

[0070] The label may be made of any suitable material and weight or
thickness. The label includes a material suitable for reproduction of
graphics and lettering onto its surface through any suitable printing
process including mechanical, electronic such as electrostatic,
magnetographic, ion or electron deposition, ink-jet printing, or any
other suitable type of printing process. At least a portion of the label
12a includes a material that is resistant to moisture. In one embodiment,
the label is a plastic. At least a portion of the label 12a includes a
synthetic plastic material such as a biaxially oriented polypropylene.
The label 12a of the illustrated embodiment is substantially clear or
transparent. It should be appreciated, however, that at least a portion
of the label may be opaque and include any suitable color.

[0071] The material of the label may be made at any weight or thickness
suitable for manipulating the label to be affixed in a suitable manner to
the surface of the drug container and durable for use of the drug
container. In an embodiment, the thickness of the substrate is at least
about 0.2 to about 5 mil or about 1 to about 3 mil. The thickness of the
substrate 12a of the drug administration safety device is about 2 mil.

[0072] It should be appreciated that the features described above are
included in each of the embodiments of the drug administration safety
device illustrated in FIGS. 2B, 2C, 2G, 2K, and 2M.

[0073] Referring to FIGS. 2D, 2E, 2F, 2H, 2I, 2J and 2L, in an embodiment,
one or more different shapes, combination of shapes or positioning of
shapes are associated with a specific drug concentration of the same
drug. In addition to the features described above, the embodiments of the
drug administration safety device illustrated in FIGS. 2D, 2E, 2F, 2H,
2I, 2J and 2L include one or more shapes displayed in their respective
drug concentration sections 26d, 26e, 26f, 26h, 26i, 26j and 26l to
differentiate different concentrations of the same drug.

[0074] For example, FIG. 5 illustrates three labels 12h, 12i and 12j,
illustrated in FIGS. 2H, 2I and 2J, respectively, operatively affixed to
three respective syringes 40h, 40i and 40j each secured to three-port
stopcock manifold 46. Although the drug name of each label is the same,
the concentration of the drug is different for each syringe. In
particular, the label 12h on syringe 40h includes a concentration of "100
mcg per mL," the label 12i on syringe 40i includes a concentration of "80
mcg per mL" and the label 12j on syringe 40j includes a concentration of
"40 mcg per mL," respectively. In the illustrated embodiment, the
different concentrations of Phenylephrine are distinguished from one
another by one or more shapes or pattern of shapes associated with the
concentration information of the label. Label 12h includes a combination
of triangles and a rectangle to differentiate the concentration of
syringe 40h from the concentrations of the other syringes 40i and 40j.
Label 12i includes a combination of two squares on either side of the
concentration of syringe 40i to distinguish the concentration from the
concentrations of syringes 40h and 40j. Label 12j includes a rectangle
outlining the concentration of syringe 40j to distinguish the
concentration from the concentrations of syringes 40h and 40i. It should
be appreciated that the absence or presence of one or more different
shapes, combination of shapes or positioning of shapes associated with a
specific drug concentration of the same drug enables a user of the drug
container to distinguish between different concentrations of the same
drug within similar containers.

[0075] Referring now to FIGS. 3A and 4D, in a further embodiment of the
drug administration safety device of the present disclosure, generally
indicated by numeral 100a, in addition to a first drug name section 120a,
a second drug name section 122a and a third drug name section 124a as
described above, the label 112a includes a fourth drug name section 134a.
The fourth orientation of the fourth drug name section 134a is different
from the first orientation of the first drug name section 120a, a second
orientation of the second drug name section 122a and a third orientation
of the third drug name section 124a. Each of the letters in the name of
the drug displayed in the fourth drug name section 134a of the label are
positioned one on top of the other and aligned along the graduation
viewing section 134a. When the label 112a is removed from its backing 16
and placed on a drug container such as a syringe 140, the user is able to
view both the graduation markings and the drug name when operating the
syringe. This embodiment also includes a drug concentration section 126a
and a variable information section 128a and a trade name section 132a.

[0076] It should be appreciated that the features described above are
included in each of the embodiments of the drug administration safety
device illustrated in FIGS. 3B, 3C, 3G, 3K, and 3L except that no shape
is used in the respective drug concentration sections. It should be
further appreciated that the features described above are included in
each of the embodiments of the drug administration safety device
illustrated in FIGS. 3D, 3E, 3F, 3H, 3I, 3J and 3M except that different
shapes are used in their respective drug concentration sections 126d,
126e, 126f, 126h, 126i, 126j and 126m to differentiate different
concentrations of the same drug.

[0077]FIG. 6 illustrates an example of one of the disclosed embodiments
attached to a syringe in use by a user. As illustrated in FIGS. 4A, 4B,
4C, 4D and 6, the features of the disclosed embodiments combine to enable
the user to view the name of the drug in virtually any orientation of the
syringe while maintaining the view of markings on the syringe and not
interfering with the function of the syringe.

[0078] It should be appreciated that the label of the drug administration
safety device may be other suitable sizes and shapes. It should also be
appreciated that the sections may be dimensioned and oriented in other
suitable manners in relation to one another and in relation to the device
or container. Although the sections including the drug name are
positioned on the label in different orientations, it should be
appreciated that other information may be displayed in different
orientations. In addition, in an alternative embodiment, one or more of
the sections of the label of the drug administration safety device may be
affixed to the device or container as separate sections that are
positioned on the same device or container as described herein.

[0079] It should also be appreciated that information displayed in the
sections of the label may include identification information, information
describing the contents of the device or any other suitable information
informing a user how to use the contents of the device or container. The
information may be presented on the label in any suitable form of
lettering, numbering, symbols, graphics and combinations thereof in any
suitable color or shade or any other suitable form of conveying
information to the user. In various embodiments, "tall-man" lettering is
employed to emphasize certain distinguishing portions of the drug name.
For example, in FIGS. 2H, 2I and 2J, the first six letters of the drug
name morphine ("PHENYL") are displayed in all caps to distinguish the
drug name from other drugs ending in "-ephrine" such as "Epinephrine."

[0080] In an alternative embodiment, the drug administration safety device
includes a label configured to be placed on an IV bag or container. The
label of the drug administration safety device of one such embodiment may
be a paper face stock which may be coated for thermal resin acceptance.
It should be appreciated that the drug administration safety device may
include any suitable mechanism of affixing the drug administration safety
device to a drug delivery device or container.

[0081] Referring now to FIG. 7, the present disclosure provides systems
and methods of differentiating information on drug administration safety
devices having similar information. In an embodiment, a scheme of shapes,
colors and shades of shapes is developed for different concentrations of
the same drug contained in a plurality of devices or containers. Each
dose of the same drug is associated with a different shape or reverse
printing within the shape. For example, the shape may include a color
that contrasts with the color of the information associated with the
shape such as white lettering in a black shape. The shape corresponding
to the dose of the drug is displayed in the drug concentration section of
the label for that drug.

[0082]FIG. 7 illustrates a labeling scheme for distinguishing between
different doses for each of the drugs, Bupivacaine, Ropivacaine and
Fentanyl. As illustrated in FIG. 7, a series of shapes and shapes with
reverse printing is used to distinguish different concentrations of the
same drug. It should be appreciated that one dose may distinguished from
the other doses by not having any shape associated with the dose.

[0083] The labeling scheme 210 for the drug Bupivacaine for example
includes a different shape or shape with reverse printing for each of
nine different doses from "0.04," to "0.375". For each dose either no
shape or a different shape or reverse printing within the shape is used
to distinguish each different concentration. According to the scheme
illustrated in FIG. 6 a dose of "0.04" does not appear within a shape; a
dose of "0.0625" appears within a rectangle, a dose of "0.075" appears
within a parallelogram; a dose of "0.1" appears within an ellipse; a dose
of "0.125" appears within a triangle; a dose of "0.15" appears within an
oval in reverse printing, a dose of "0.2" appears within a rectangle in
reverse printing, a dose of "0.25" appears within a parallelogram in
reverse printing and a dose of "0.375" appears within a triangle in
reverse printing.

[0084] The scheme illustrated in FIG. 7 also includes the same scheme or
sequence of shapes for increasing concentrations or doses of other drugs.
In other words, the sequence of no shape, rectangle, parallelogram,
ellipse, triangle, ellipse of reverse printing, rectangle with reverse
printing, parallelogram with reverse printing and triangle with reverse
printing for increasing doses of Bupivacaine may be the same sequence for
increasing doses of other drugs. As illustrated in FIG. 7, the labeling
scheme for Bupivacaine 210 is also used for different doses of
Fentanyl-Bupivacaine. Alternatively, the sequence of shapes may be
different for increasing doses of each drug such as for the Ropivacaine
scheme 220 and Fentanyl scheme 230 illustrated in FIG. 7.

[0085] It should be appreciated that any suitable shapes, shading within
the shapes, patterns of shapes, positions of the shapes in relation to
information and or combinations thereof may be included in a labeling
scheme for a particular drug to distinguish different doses of that drug.

[0086] Referring now to FIGS. 8 through 42, in other embodiments, the drug
administration safety device includes a label configured to be placed on
any suitable surface of a drug storage or delivery device or container
such as an IV bag, a cassette, a drug vial, syringe, or any other device
or container containing an agent or drug. In an embodiment, the label
includes any feature or combination of features disclosed herein. For
example, as illustrated in FIG. 8, the label information on label 310 may
include one or more drug name sections 312, drug concentration sections
314 and 314b, variable information sections 316a, 316, b, 316c, 316d,
316e and 316f, manufacturer, trademark and branding sections 318a and
318b and warning statement sections 320a and 320b in one or more
orientations.

[0087] As illustrated, shapes are used to distinguish between different
information presented on the label, such as names of drugs and doses of
drugs. As illustrated in FIG. 8, for example, in an embodiment, the label
information is situated within a shape. It should be appreciated that in
one embodiment the label information within the shape is in reverse
printing. The drug information situated in shape 330 may be the drug
concentration as illustrated in the embodiment of FIG. 8, the drug name,
as illustrated in the embodiment of FIG. 11 or both as illustrated in
FIG. 12.

[0088] In an embodiment, the drug name and drug dose are situated within
two different shapes. For example, as illustrated in FIG. 10, the drug
name is situated within an oval shape 332 and the drug concentration is
situated in a rectangle shape 334. In alternative embodiments, the shapes
are placed adjacent to the label information such as shapes 336a and 336b
adjacent to the drug name as illustrated in FIGS. 13, 14 and 15.

[0089] In an embodiment, different portions of label information are
situated within one or more shapes. For example, as illustrated in FIG.
26, the concentration of Oxytocin, "20 units per 500 ml" is situated
within a rectangle shape 338 having rounded corners. Within the rectangle
shape, the dose of "20 units" is further situated inside a second
rectangle shape 340. It should be appreciated that the plurality of
shapes may be the same or different. Further examples include, but are
not limited to, the embodiments illustrated in FIGS. 16, 17, 19, 23 and
24.

[0090] In various embodiments, the configuration of the shapes with
respect to the label information is different for different doses of the
same drug, different variations of the similar drug names or any other
distinction in the label that is advantageous and desirable to make.

[0091] In various embodiments, the label information includes one or more
warning statements such as "Verify Drug", "IV Use Only" and "Epidural Use
Only". In an embodiment, the warning statement is situated within a
shape. For example, as illustrated in FIGS. 8 and 9, the warning
statement "Verify Drug" is situated within an octagon or a stop sign 342,
indicating that the user should "stop" and read the warning statement.
Also, in FIGS. 8 to 15, the warning statement, "IV Use Only", is situated
within one or more shapes such as rectangles 344 to highlight the
statement. The shapes are filled with a particular shade or color in
various embodiments and include an outline of the shape in the same or
different shade or color. For example, as illustrated in FIGS. 8 and 9,
the stop-sign shape 342 including the warning statement "Verify Drug" may
include the color red. Also, in FIGS. 16 to 19, the inner rectangle 344
including the warning statement, "Epidural Use Only", includes the color
red, and the outer rectangle 346 includes the color yellow surrounded by
a black box.

[0092] In an embodiment, the warning statements are positioned on the
label to gain the attention of the user such as directly above or
adjacent to the drug name. For example, in FIGS. 8 and 9, the stop sign
is prominently situated adjacent to the drug name in the middle of the
label. In FIGS. 8 to 15, the warning statement "IV Use Only" is
prominently situated in the upper right-hand corner of the label so as to
be visible in the same vertical plane as the drug name.

[0093] In an embodiment, at least one highlighting technique, including
shapes, colors, positions and configurations, are uniform for each
warning statement. In an embodiment, warning statements, and, in
particular, warning statements indicating a particular route of
administration, such as "IV Use Only" and "Epidural Use Only" are
positioned in the same position on each label for each route of
administration. For example, each label illustrated in FIGS. 8 to 15,
each with different label information, includes the warning statement,
"IV Use Only", situated in the upper right-hand corner of each label.
Each label illustrated in FIGS. 16 to 19, each with different label
information, includes, the warning statement, "Epidural Use Only",
situated at the top of each label.

[0094] It should be appreciated that the configuration of label
information and size and shape of the labels in different embodiments are
configured for the particular drug delivery device with which the label
is used. In an embodiment, each label for a particular type of drug
delivery device includes at least one common shape, color, position and
configuration of the label information. For example, in an embodiment,
each of the exemplary embodiments illustrated in FIGS. 20 to 22 are
configured to be placed on IV PCA (Patient Controlled Analgesia) bags,
vials or drug delivery cassettes. In a particular embodiment, the warning
statement, "IV use only", appears at the top of each label to be placed
on an IV PCA bag, vial or drug delivery cassette. It should also be
appreciated that the arrangement of label information may depend on the
visibility of certain portions of the label when the drug delivery
container is place in a drug delivery device such as a syringe in a pump.

[0095] It should be further appreciated that the label elements and
information in the illustrated embodiments are not intended to show exact
wording, font styles, colors or sizes.

[0096] It should be understood that various changes and modifications to
the presently preferred embodiments described herein will be apparent to
those skilled in the art. Such changes and modifications can be made
without departing from the spirit and scope of the present subject matter
and without diminishing its intended advantages. It is therefore intended
that such changes and modifications be covered by the appended claims.